Abstract

Importance: Current treatments for moderate to severe atopic dermatitis (AD) in children are limited by incomplete efficacy, long time to benefit, and parental concerns about safety. This study evaluated a novel ointment for treating AD containing 0.83% hydrocortisone and 17% dispersed ethanol gel micro bubbles.

Observations:20 children with moderate to severe AD participated in a one-week double blind, randomized, and controlled clinical trial. They were randomly assigned to apply BID either an ointment with 1% hydrocortisone ointment (HC) or a novel ointment containing 1% hydrocortisone and dispersed ethanol gel droplets (HC-EG).

The primary endpoint was superiority of HC-EG over HC ointment in SCORAD score improvement during therapy. A secondary endpoint was improvement in pruritus score during therapy. Both the primary and secondary endpoints were reached in this study. SCORAD score improved 74% on average with HC-EG ointment vs 41% with HC ointment (p=.02). Pruritus score improved 68% on average with HC-EG ointment vs 37% with HC ointment (p=.009). No toxicity requiring stopping therapy was observed in either treatment group.

Conclusions and Relevance: Inthis small controlled study HC-EG ointment was superior to HC ointment both in improving visible rash and pruritus of AD. Parents felt HC-EG ointment was safe because it contains no prescription corticosteroids, prescription immunosuppressants, or antibiotics. Independent larger studies would be a next step in evaluating further this new way to treat AD.

National Institute for Health and Care Excellence, “Atopic eczema in children: Management of atopic eczema in children from birth up to the age of 12 years”, www.nice.org.uk/nicemedia/pdf/CG057FullGuideline.pdf (accessed2009 March 15)